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Depression And Primary-care Partnership for Effectiveness-implementation Research (DAPPER)

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ClinicalTrials.gov Identifier: NCT03466346
Recruitment Status : Not yet recruiting
First Posted : March 15, 2018
Last Update Posted : March 16, 2018
Sponsor:
Collaborators:
University of Nairobi
National Institute of Mental Health (NIMH)
Kenya Medical Research Institute
University of California, San Diego
Makerere University
Information provided by (Responsible Party):
Susan Meffert, University of California, San Francisco

Brief Summary:
Despite carrying the vast majority of the global mental disorder burden, 75% of adults with mental disorders in Low and Middle Income Countries have no access to services. This study will test strategies for integrating evidence-based depression treatments with primary care services at a large public sector hospital and conduct robust cost and cost-benefit analyses of each treatment to produce a "menu" of cost-benefit options for integrated depression care with corresponding effectiveness and implementation values. The project is relevant to the mission of the National Institutes of Mental Health because it addresses mental health care delivery and related health economics at the individual, clinical and systems levels.

Condition or disease Intervention/treatment Phase
Depression, Unipolar Drug: Fluoxetine Behavioral: Interpersonal Psychotherapy Not Applicable

Detailed Description:

Dominated by depression, mental disorders are a leading cause of global disability. Most of the disease burden is in Low and Middle Income Countries (LMICs), where 75% of adults with mental disorders have no service access. Despite nearly 15 years of efficacy studies showing that local non-specialists can provide evidence-based care for depression in LMICs, few studies have advanced to implementation research. As emphasized by a recent World Health Organization (WHO) initiative, integration of depression treatment into existing systems of care is critical to achieving public health impact.

The research team has worked in western Kenya for 5 years with a UCSF-Kenya collaboration that supports integrated HIV services at over 70 primary healthcare facilities in Kisumu County (Family AIDS Care and Education Services [FACES]). With high prevalence of Major Depressive Disorder (MDD) in Kenyan primary care populations (26.3%, 3-5 times higher than in the U.S.), treatment for depression is a top concern for Kenyan mental health leaders. Kenyan leaders recently launched a government-funded initiative to scale-up treatment for mental disorders in primary healthcare, prioritizing depression. Yet, they lack an evidence base for the two essential treatments -psychotherapy and second generation antidepressants—without which Kenyan care scale-up will fall short of its potential. The proposed research responds to this need.

The investigators will partner with local and national mental health stakeholders in Kenya to evaluate: (1) non-specialist delivery of evidence-based depression treatment integrated within existing healthcare centers in regards to clinical effectiveness and implementation parameters; including (2) costs and cost-benefit ratios for depression care. Given that evidence-based psychotherapy and second-generation antidepressants are the two leading first-line treatments for depression and are feasible to deliver in Kenya, the investigators' goal is to test an implementation strategy for improving equitable access to these treatments by integrating them with primary care. The study uses an effectiveness-implementation hybrid design type I to assess outcomes of non-specialist delivered Interpersonal Psychotherapy (IPT) compared to fluoxetine, including assessment of the service delivery mechanism.

The study's approach differs from most prior work in the field because it uses an effectiveness-implementation design, compares outcomes for IPT versus second generation antidepressant, integrates depression treatment into primary care, and analyses depression care costs and cost-benefit ratios for each treatment arm. The results of the proposed research will be significant in two ways: (1) they will produce a scalable strategy for delivering depression treatments in sub-Saharan Africa using non-specialists integrated within existing primary care structures and (2) they will produce a policy maker "menu" of short and long-term cost-benefit options for integrated depression care with corresponding effectiveness and implementation values.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: fluoxetine versus interpersonal psychotherapy (IPT) for treatment of Major Depressive Disorder (MDD)
Masking: Single (Outcomes Assessor)
Masking Description: participants will be evaluated by an outcomes assessor that is not aware of which treatment the participant is receiving. This will be achieved by keeping the randomization key locked and accessible only to the study coordinator and investigators. Participants who are scheduled for assessments will be reminded not to spontaneously disclose their treatment modality to the outcomes assessor.
Primary Purpose: Health Services Research
Official Title: Depression And Primary-care Partnership for Effectiveness-implementation Research
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Fluoxetine

Arm Intervention/treatment
Active Comparator: Interpersonal psychotherapy
IPT was developed in the 1980s by Gerald Klerman and Myrna Weissman to address interpersonal issues in depression. IPT is now considered evidence-based, first-line treatment for depression. IPT improves symptoms by addressing problems in social relationships. IPT is traditionally delivered as weekly one-hour sessions over 12 weeks, focused on one interpersonal problem area.
Behavioral: Interpersonal Psychotherapy
PT was developed in the 1980s by Gerald Klerman and Myrna Weissman to address interpersonal issues in depression. IPT is now considered evidence-based, first-line treatment for depression. IPT improves symptoms by addressing problems in social relationships. IPT is traditionally delivered as weekly one-hour sessions over 12 weeks, focused on one interpersonal problem area.
Other Name: IPT

Active Comparator: fluoxetine
Fluoxetine is a selective serotonin reuptake inhibitor that is FDA approved for the treatment of depression. Compared to placebo, fluoxetine is more likely to produce symptom response for MDD. Despite the interim development of many other antidepressants since the development of fluoxetine, it remains a first line treatment for depression.
Drug: Fluoxetine
Fluoxetine is a selective serotonin reuptake inhibitor that is FDA approved for the treatment of depression. Compared to placebo, fluoxetine is more likely to produce symptom response for MDD. Despite the interim development of many other antidepressants since the development of fluoxetine, it remains a first line treatment for depression.




Primary Outcome Measures :
  1. Change in the Mini International Psychiatric Interview (MINI) depression module [ Time Frame: baseline, 1.5, 3, 6, 12, 18, 24 and 30 months ]
    Change in the diagnostic measure of major depressive disorder


Secondary Outcome Measures :
  1. Cost Effectiveness [ Time Frame: baseline, 1.5, 3, 6, 12, 18, 24 and 30 months ]
    cost of treatment including opportunity costs (e.g., transport, childcare, lost wages) provider time, other healthcare utilization/hospitalizations

  2. Cost Benefit [ Time Frame: baseline, 1.5, 3, 6, 12, 18, 24 and 30 months ]
    ratio of economic gains and costs associated with each intervention arm



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Kisumu County Hospital (KCH) adult primary care outpatient clinic attendees who screen positive for MDD on the Mini International Neuropsychiatric Interview (MINI);
  2. Ability to attend weekly IPT sessions/fluoxetine monitoring; (3) 18 years or older

Exclusion Criteria:

  1. Cognitive dysfunction compromising ability to participate in IPT or accurately take fluoxetine (lack of orientation to person, place, time and situation)
  2. acute suicidality (moderate or high score on the MINIsuicidality module) requiring higher level of care
  3. drug/alcohol use disorders requiring substance use treatment (AUDIT score of 8 or higher, DAST score of 3 or higher)
  4. history of mania or requiring treatment for hypomania (positive score on MINI mania/hypomania module)
  5. Outside mental health treatment during the study treatment phases (any mental health treatment is allowed during follow-up phases and is recorded by study team).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03466346


Contacts
Contact: Susan M Meffert, MD, MPH 4154767532 Susan.meffert@ucsf.edu
Contact: Linnet Ongeri, MBChB, MMed +254 0722615999 linongeri@gmail.com

Sponsors and Collaborators
University of California, San Francisco
University of Nairobi
National Institute of Mental Health (NIMH)
Kenya Medical Research Institute
University of California, San Diego
Makerere University
Investigators
Principal Investigator: Caleb J Othieno, MDChB, MMed University of Nairobi
Principal Investigator: Susan M Meffert, MD, MPH University of California, San Francisco

Responsible Party: Susan Meffert, Associate Professor of Psychiatry, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03466346     History of Changes
Other Study ID Numbers: 1U01MH115512 ( U.S. NIH Grant/Contract )
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: March 16, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: NIMH Data Archive The National Institutes of Health (NIH) and NIMH have developed a federation of data repositories called the NIMH Data Archive (NDA) to store the collection of data from participants in research studies related to mental health, regardless of the source of funding. The extensive information collected by these studies, and subsequently stored in the National Database for Autism Research (NDAR), the NIH Pediatric MRI Repository (PedsMRI), the National Database for Clinical Trials Related to Mental Illness (NDCT), and the Research Domain Criteria Database (RDoCdb) provides a rare and valuable scientific resource. The NIH and the NIMH seek to encourage the use of these resources to achieve rapid scientific progress. In order to take full advantage of such resources and maximize their research value, it is important that data be made available, on appropriate terms and conditions, to the largest possible number of qualified investigators in a timely manner.
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: Data will be made available to the NIMH data archive as soon as it is verified as clean and complete, with at least annual updates throughout the duration of the study. Data will be be available indefinitely or for as long as the NIMH repositories supports the electronic data storage.
Access Criteria: The investigative team and our NIMH and GACD partners will review requests for data. Evaluation will include scientific merit of the proposal, overlap versus building upon the study goals.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors